TETANUS TOXOID ADSORBED SUSPENSION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

TETANUS TOXOID ADSORBED

Доступна з:

ID BIOMEDICAL CORPORATION OF QUEBEC

Код атс:

J07AM01

ІПН (Міжнародна Ім'я):

TETANUS TOXOID

Дозування:

5LF

Фармацевтична форма:

SUSPENSION

Склад:

TETANUS TOXOID ADSORBED 5LF

Адміністрація маршрут:

INTRAMUSCULAR

Одиниць в упаковці:

5ML/5 X 0.5ML

Тип рецепту:

Schedule D

Терапевтична области:

TOXOIDS

Огляд продуктів:

Active ingredient group (AIG) number: 0106214001; AHFS:

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2005-08-03

Характеристики продукта

PRODUCT MONOGRAPH
TETANUS TOXOID ADSORBED
DIN 01914502
Single dose ampoule (0.5 mL)
For active immunization against tetanus
ID Biomedical Corporation
Date of preparation: October 27, 2004
525 Cartier Blvd. West
Laval, PQ
H7V 3S8
Control#: 094858
PMTA01/Version 2.00
PMTA01/Version 2.00
TETANUS
Active immunization
TOXOID
against tetanus
ADSORBED
Keep in the refrigerator between 2
°
C and 8
°
C
DIN 01914502
Page 1 of 5
<
DESCRIPTION
Tetanus Toxoid Adsorbed as supplied by ID Biomedical Corporation is a
sterile, cloudy, uniform
suspension of tetanus toxoid, adsorbed on aluminum phosphate, in an
isotonic sodium chloride
solution.
Each dose (0.5 mL) contains 5 Lf tetanus toxoid, 1.5 mg aluminum
phosphate and 0.01% thimerosal
as a preservative.
<
INDICATIONS
Tetanus Toxoid Adsorbed is indicated for active immunization against
tetanus. It may be used for
primary immunization and reinforcing doses against tetanus, as well as
in the event of injury for
which tetanus prophylaxis is indicated.
<
CONTRA-INDICATIONS
Immunization with Tetanus Toxoid Adsorbed should be postponed in the
presence of any acute
illness, including febrile illness.
It is contra-indication to administer this vaccine to individuals
known to be sensitive to thimerosal.
<
WARNING
If the vaccine is administered to persons receiving immuno suppressive
therapy, it should be borne
in mind that the expected antigenic response may not be obtained.
<
PRECAUTIONS
Individuals who are hypersensitive to the components of the vaccine
may develop allergic reactions.
Sterile epinephrine hydrochloride solution 1:1000 should always be
readily available in case an
acute anaphylactic reaction should occur.
Frequent reinforcing (booster) doses of tetanus toxoid in the presence
of adequate or excessive
serum levels of tetanus antitoxin have been associated with increased
incidence and severity of
reactions and should be avoided
4
.
PMTA01/Version 2.00
TETANUS
Active immunization
TOXOID
against tetanus
ADSORBED
Keep in the refrigerator between 2
°
C and 8
°
C
DIN 01914502